Safety & Immunogenicity of 1 Dose of GSK134612 in Children 12-14 Months and 3-5 Years Old
May 7, 2018 updated by: GlaxoSmithKline
Evaluate the Immunogenicity, Reactogenicity, Safety of 4 Different Formulations of GSK Biologicals' Conjugate Vaccine (MenACWY) vs 1 Dose of MenC-CRM197 or Mencevax™ ACWY in Children Aged 12-14 Months & 3-5 Years
The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one dose of four different formulations of the MenACWY conjugate vaccine when given to healthy children aged 12-14 months and 3-5 years. The selection of the best formulation will be based on data obtained up to one month after the vaccine dose.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study Overview
Status
Completed
Conditions
Detailed Description
The study will enrol subjects of 12 to 14 months of age and subjects of 3 to 5 years of age. 3 formulations of GSK's MenACWY conjugate vaccine will be administered in a double-blind manner, while the 4th one will be single-blinded. Administration of the candidate vaccine or the active controls (MenC-CRM197 or Mencevax™ ACWY) will be done in an open manner. The study will be conducted in two stages: The primary vaccination phase (Study Stage 1) of the study will include all subjects; the second (booster/persistence) phase of the study (Study Stage 2) will include subjects in the active control groups and in the group which was primed with the selected MenACWY formulation.
The study will be conducted in a double-blind manner for groups receiving formulations A, B, C and in single blind manner with respect to the group receiving formulation D. The control vaccines will be administered in an open manner with respect to the investigational vaccination regimens.
Each group will have one blood sample prior to and one blood sample one month after the first vaccine dose.
Study Type
Interventional
Enrollment (Actual)
461
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Eferding, Austria, A-4070
- GSK Investigational Site
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Graz, Austria, A-8036
- GSK Investigational Site
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Salzburg, Austria, A-5020
- GSK Investigational Site
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Vienna, Austria, A-1020
- GSK Investigational Site
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Villach, Austria, A-9500
- GSK Investigational Site
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Wels, Austria, A-4600
- GSK Investigational Site
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Athens, Greece, 11527
- GSK Investigational Site
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Heraklion, Crete, Greece, 71110
- GSK Investigational Site
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Ioannina, Greece, 452 21
- GSK Investigational Site
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Komotini, Greece, 69100
- GSK Investigational Site
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Koufalia, Greece, 571 00
- GSK Investigational Site
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Markopoulo, Greece, 19003
- GSK Investigational Site
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N. Efkarpia, Thessaloniki, Greece, 564 29
- GSK Investigational Site
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Nea Makri, Greece, 19005
- GSK Investigational Site
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Rio/Patras, Greece, 26500
- GSK Investigational Site
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Thessaloniki, Greece, 54636
- GSK Investigational Site
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Tripolis, Greece, 22100
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 5 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- A male or female between, and including 12 and 14 months or 3 and 5 years of age at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Previously completed routine childhood vaccinations to the best of his/her parents'/guardians' knowledge. For pertussis vaccination, the children aged 12-14 months should have been vaccinated with an acellular pertussis vaccine.
Exclusion criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the first dose of vaccine and up to one month after administration of each study vaccine dose with the exception of oral polio vaccine (OPV).
- Previous vaccination against meningococcal serogroup A, C, W-135 or Y disease.
- Administration of a H. influenzae type b, diphtheria or tetanus vaccine within 3 months before the first dose of vaccine.
For subjects aged 12-14 months at enrolment:
- For Austria: DTPa-HBV-IPV/Hib booster vaccination in the second year of life: these booster vaccines will be given at Visit 2.
- For Greece: DTPa-IPV/Hib booster vaccination in the second year of life: these booster vaccines will be given at Visit 2.
- History of meningococcal serogroup A, C, W-135 or Y disease.
- Known exposure to meningococcal serogroup A, C, W-135 or Y disease within the previous year.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: GSK134612A Form1 (T), Primary Group
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
|
One intramuscular dose during the primary vaccination
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only
One subcutaneous dose during the primary vaccination study in subjects of 3-5 years of age (Group E) and intramuscular administration of 1/5 dose during the booster vaccination study in subjects of 12-14 months of age (Groups A and E)
|
|
Experimental: GSK134612A Form2 (T), Primary Group
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
|
One intramuscular dose during the primary vaccination
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only
|
|
Experimental: GSK134612A Form3 (T), Primary Group
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
|
One intramuscular dose during the primary vaccination
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only
|
|
Experimental: GSK134612A Form4 (T), Primary Group
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
|
One intramuscular dose during the primary vaccination
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only
|
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Active Comparator: Control (T), Primary Group
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
|
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only
One subcutaneous dose during the primary vaccination study in subjects of 3-5 years of age (Group E) and intramuscular administration of 1/5 dose during the booster vaccination study in subjects of 12-14 months of age (Groups A and E)
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age
|
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Experimental: GSK134612A Form1 (C), Primary Group
Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
|
One intramuscular dose during the primary vaccination
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only
|
|
Experimental: GSK134612A Form2 (C), Primary Group
Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
|
One intramuscular dose during the primary vaccination
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only
|
|
Experimental: GSK134612A Form3 (C), Primary Group
Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
|
One intramuscular dose during the primary vaccination
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only
|
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Experimental: GSK134612A Form4 (C), Primary Group
Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
|
One intramuscular dose during the primary vaccination
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only
|
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Active Comparator: Control (C), Primary Group
Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
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One subcutaneous dose during the primary vaccination study in subjects of 3-5 years of age (Group E) and intramuscular administration of 1/5 dose during the booster vaccination study in subjects of 12-14 months of age (Groups A and E)
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Experimental: GSK134612A Form1 (T), Booster Group
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
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One intramuscular dose during the primary vaccination
One subcutaneous dose during the primary vaccination study in subjects of 3-5 years of age (Group E) and intramuscular administration of 1/5 dose during the booster vaccination study in subjects of 12-14 months of age (Groups A and E)
|
|
Active Comparator: Control (T), Booster Group
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer's Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
|
One subcutaneous dose during the primary vaccination study in subjects of 3-5 years of age (Group E) and intramuscular administration of 1/5 dose during the booster vaccination study in subjects of 12-14 months of age (Groups A and E)
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age
|
|
Experimental: GSK134612A Form1 (C), Booster Group
Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.
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One intramuscular dose during the primary vaccination
|
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Active Comparator: Control (C), Booster Group
Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer's Meningitec™ conjugate vaccine, did not receive any booster vaccination.
|
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of Subjects With an Immune Response to Different Meningococcal Serogroups
Time Frame: One month after the first vaccine dose (Month 1)
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A responder to serum bactericidal assay meningococcal serogroups A, C, W and Y, using rabbit complement (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) was defined as follows: -for initially seronegative subjects (antibody titers < 1:8 for rSBA-Men), a subject achieving a post-vaccination rSBA-Men antibody titer of ≥ 1:32; - for initially seropositive subjects (antibody titers ≥ 1:8 for rSBA-Men), a subject having a ≥ 4-fold increase in rSBA-Men antibody titer from pre to post vaccination.
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One month after the first vaccine dose (Month 1)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of Seroprotected Subjects Against Different Meningococcal Serogroups
Time Frame: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
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A seroprotected subject against meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY assessed, was defined as having antibody titers greater than or equal to (≥) 1:8.
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Prior to (Month 0) and one month after (Month 1) the first vaccine dose
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Number of Seropositive Subjects for Different Anti-meningococcal Serogroups
Time Frame: Prior to (Month 0) and one month after (Month 1) after the first vaccine dose
|
A seropositive subject for meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Y assessed, was defined as having antibody titers greater than or equal to (≥) 1:128.
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Prior to (Month 0) and one month after (Month 1) after the first vaccine dose
|
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Antibody Titers Against Different Meningococcal Serogroups
Time Frame: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
|
Antibody titers against meningococcal serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and MenY) have been assessed, using rabbit complement and expressed as geometric mean titers (GMTs).
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Prior to (Month 0) and one month after (Month 1) the first vaccine dose
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Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides
Time Frame: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
|
A seropositive subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the cut-off value of 0.3 micrograms per milliliter (μg/mL).
Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).
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Prior to (Month 0) and one month after (Month 1) the first vaccine dose
|
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Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides
Time Frame: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
|
A seroprotected subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the value of 2.0 micrograms per milliliter (μg/mL).
Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).
|
Prior to (Month 0) and one month after (Month 1) the first vaccine dose
|
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Antibody Concentrations Against Different Meningococcal Polysaccharides
Time Frame: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
|
The meningococcal polysaccharides assessed included polysaccharide A (anti-PSA), polysaccharide B (anti-PSB), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY).
Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
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Prior to (Month 0) and one month after (Month 1) the first vaccine dose
|
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Number of Seropositive Subjects for Anti-tetanus (Anti-T)
Time Frame: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
|
A seropositive subject for anti-tetanus was defined as having antibody concentrations greater than or equal to (≥) the cut-off value of 0.1 international units per milliliter (IU/mL).
Antibody titers were determined by enzyme-linked immunosorbent assay (ELISA).
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Prior to (Month 0) and one month after (Month 1) the first vaccine dose
|
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Antibody Concentrations Against Tetanus (Anti-T)
Time Frame: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
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Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) method, presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
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Prior to (Month 0) and one month after (Month 1) the first vaccine dose
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Number of Toddlers With Any Solicited Local Symptoms
Time Frame: During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose
|
The toddlers subgroup received 2 primary vaccine doses, as follows: first dose of a meningococcal vaccine and second dose of a diphtheria, tetanus and acellular pertusis-containing vaccine.
Assessed solicited local symptoms were pain, redness and swelling.
Any = occurrence of the symptom regardless of intensity grade.
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During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose
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Number of Children With Any Solicited Local Symptoms
Time Frame: During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose
|
The children subgroup received one dose of the meningococcal vaccine.
Assessed solicited local symptoms were pain, redness and swelling.
Any = occurrence of the symptom regardless of intensity grade.
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During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose
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Number of Toddlers With Any Solicited General Symptoms
Time Frame: During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose
|
The toddlers subgroup received 2 primary vaccine doses, as follows: first dose of a meningococcal vaccine and second dose of a diphtheria, tetanus and acellular pertusis-containing vaccine.
Assessed solicited general symptoms included drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability and loss of appetite.
Any = incidence of a particular symptom regardless of intensity or relationship to vaccination.
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During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose
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Number of Children With Any Solicited General Symptoms
Time Frame: During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose
|
The children subgroup received one primary meningococcal vaccine dose.
Assessed solicited general symptoms included drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability and loss of appetite.
Any = incidence of a particular symptom regardless of intensity or relationship to vaccination.
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During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose
|
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Number of Seroprotected Subjects Against Different Meningococcal Serogroups
Time Frame: At one month (M1) and 12 months (M12) post-primary vaccination
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A seroprotected subject against meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY assessed, was defined as having antibody titers greater than or equal to (≥) 1:8.
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At one month (M1) and 12 months (M12) post-primary vaccination
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Number of Seropositive Subjects for Different Anti-meningococcal Serogroups
Time Frame: At one month (M1) and 12 months (M12) post-primary vaccination
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A seropositive subject for meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Y assessed, was defined as having antibody titers greater than or equal to (≥) 1:128.
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At one month (M1) and 12 months (M12) post-primary vaccination
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Antibody Titers Against Different Meningococcal Serogroups
Time Frame: At one month (M1) and 12 months (M12) post-primary vaccination
|
Antibody titers against meningococcal serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and MenY) have been assessed, using rabbit complement and expressed as geometric mean titers (GMTs).
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At one month (M1) and 12 months (M12) post-primary vaccination
|
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Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides
Time Frame: At one month (M1) and 12 months (M12) post-primary vaccination
|
A seropositive subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the cut-off value of 0.3 micrograms per milliliter (μg/mL).
Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).
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At one month (M1) and 12 months (M12) post-primary vaccination
|
|
Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides
Time Frame: At one month (M1) and 12 months (M12) post primary vaccination
|
A seroprotected subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the value of 2.0 micrograms per milliliter (μg/mL).
Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).
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At one month (M1) and 12 months (M12) post primary vaccination
|
|
Antibody Concentrations Against Different Meningococcal Polysaccharides
Time Frame: At one month (M1) and 12 months (M12) post-primary vaccination
|
The meningococcal polysaccharides assessed included polysaccharide A (anti-PSA), polysaccharide B (anti-PSB), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY).
Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
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At one month (M1) and 12 months (M12) post-primary vaccination
|
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Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups
Time Frame: Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination
|
A seropositive subject for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY was defined as a vaccinated subject with antibody titers greater than or equal to (≥) 1:128, while for a seroprotected subject, titers were ≥1:8.
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Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination
|
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Antibody Titers Against Different Meningococcal Serogroups
Time Frame: Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination
|
Antibody titers against meningococcal serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and MenY) have been assessed, using rabbit complement and expressed as geometric mean titers (GMTs).
|
Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination
|
|
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides
Time Frame: Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination
|
A seropositive subject for anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY was defined as a vaccinated subject with antibody concentrations greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL), while for a seroprotected subject, antibody concentrations were ≥ 2.0 μg/mL.
|
Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination
|
|
Antibody Concentrations Against Different Meningococcal Polysaccharides
Time Frame: Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination
|
The meningococcal polysaccharides assessed included polysaccharide A (anti-PSA), polysaccharide B (anti-PSB), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY).
Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
|
Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination
|
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Number of Subjects With Any Solicited Local Symptoms
Time Frame: During the 8-day (Days 0-7) post-vaccination period following booster dose
|
Assessed solicited local symptoms were pain, redness and swelling.
Any = occurrence of the symptom regardless of intensity grade.
|
During the 8-day (Days 0-7) post-vaccination period following booster dose
|
|
Number of Subjects With Any Solicited General Symptoms
Time Frame: During the 8-day (Days 0-7) post-vaccination period following booster dose
|
Assessed solicited general symptoms were drowsiness, fever [defined as rectal temperature equal to or above 38.0
degrees Celsius (°C)], irritability and loss of appetite.
Any = incidence of a particular symptom regardless of intensity or relationship to vaccination.
|
During the 8-day (Days 0-7) post-vaccination period following booster dose
|
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Number of Subjects With Any Unsolicited Adverse Events (AEs) After the Primary Vaccination
Time Frame: Within 31 days (Days 0-30) after the primary meningococcal vaccination
|
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
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Within 31 days (Days 0-30) after the primary meningococcal vaccination
|
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Number of Subjects With Any Unsolicited AEs During the Primary Vaccination
Time Frame: Within 31 days (Days 0-30) post-vaccination with diphteria, tetanus and acellular pertusis-containing vaccine, during the primary vaccination
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An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
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Within 31 days (Days 0-30) post-vaccination with diphteria, tetanus and acellular pertusis-containing vaccine, during the primary vaccination
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Number of Subjects With Any Unsolicited AEs
Time Frame: Within 31 days (Days 0-30) after the booster vaccination
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An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
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Within 31 days (Days 0-30) after the booster vaccination
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Number of Subjects With Serious Adverse Events (SAEs)
Time Frame: During the primary vaccination study (from Month 0 up to Month 2)
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Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
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During the primary vaccination study (from Month 0 up to Month 2)
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Number of Subjects With SAEs
Time Frame: Since the last study contact in the primary study up to the end of the booster study (from Month 2 up to Month 13)
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Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
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Since the last study contact in the primary study up to the end of the booster study (from Month 2 up to Month 13)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 24, 2005
Primary Completion (Actual)
March 1, 2006
Study Completion (Actual)
March 3, 2006
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Actual)
June 8, 2018
Last Update Submitted That Met QC Criteria
May 7, 2018
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Neisseriaceae Infections
- Meningococcal Infections
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Immunologic Factors
- Protective Agents
- Anticoagulants
- Antidotes
- Chelating Agents
- Sequestering Agents
- Iron Chelating Agents
- Calcium Chelating Agents
- Vaccines
- Edetic Acid
- Pentetic Acid
Other Study ID Numbers
- 103533
- 103534 (Other Identifier: GSK)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study Data/Documents
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Dataset Specification
Information identifier: 103533Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Informed Consent Form
Information identifier: 103533Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Statistical Analysis Plan
Information identifier: 103533Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Individual Participant Data Set
Information identifier: 103533Information comments: For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 103533 are summarised with study 103534 on the GSK Clinical Study Register.
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Study Protocol
Information identifier: 103533Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Clinical Study Report
Information identifier: 103533Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.